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Bayer
NEWS

Bayer Reports the US FDA’s Approval of Kerendia (Finerenone) to Treat Heart Failure (HF)

Shots: The US FDA has approved Kerendia/Firialta (10, 20, & 40mg) for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits authorization in China, EU & Japan, with global applications planned Approval was based on the P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where…
July 14, 2025

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NEWS

GSK Reports the US FDA’s Application Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has accepted application of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs.; FDA decision is anticipated H1’26. GSK is also seeking expanded RSV vaccine indications in other regions, incl. the EEA & Japan Submission was based on P-IIIb trial (n=1458) assessing immune response & safety…
July 14, 2025

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Merck Animal Health
NEWS

FDA Approves Merck Animal Health’s Bravecto Quantum to Treat and Protect Dogs from Fleas and Ticks

Shots: The US FDA has approved Bravecto Quantum (Fluralaner for Extended-Release Injectable Suspension), a once-yearly injectable for flea and tick protection in dogs, will be available in U.S. veterinary clinics by Aug, 2025 Bravecto Quantum kills adult fleas and controls flea and tick infestations (Ixodes scapularis, Dermacentor variabilis, Rhipicephalus sanguineus) for 12 mos., and Amblyomma…
July 11, 2025

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NEWS

Exactech Reports the US FDA 510(k) Clearance of Equinoxe Scapula Reconstruction System for Acromial Stress Fractures

Shots: Exactech has received the US FDA 510(k) clearance for the Equinoxe Scapula Reconstruction System to treat acromial & scapular spine fractures; limited US pilot launch is expected later this year Equinoxe Scapula Reconstruction System allows orthopedic surgeons to treat scapular fractures using single & dual plating techniques, which is compatible with any rTSA implant…
July 10, 2025

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NEWS

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Shots: The US FDA has accepted sNDA of Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, ineligible for intensive induction CT (PDUFA: Feb 25, 2026) sNDA was backed by P-IIb (ASCERTAIN-V) trial in 101 adults with newly diagnosed AML ineligible for intensive induction CT, where pts…
July 10, 2025

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NEWS

Mendaera’s Focalist Robotic System Secures the US FDA 510(k) Clearance for Ultrasound-Guided Procedures

Shots: Mendaera has received the US FDA’s 510(k) clearance for Focalist robotic system for ultrasound-guided procedures Mendaera will begin a limited launch of its Focalist system in 2025 to initially support urology procedures like PCNL, expanding to other specialties, with full commercialization expected in 2026 Focalist is designed to support precise & consistent needle placement…
July 9, 2025

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NEWS

KalVista Reports the US FDA’s Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

Shots: The US FDA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.), with US availability expected immediately Approval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries & KONFIDENT-S OLE study KONFIDENT data was published in The NEJM, which showed…
July 7, 2025

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